Global Pharmacovigilance Lead

hace 4 semanas


Madrid, Madrid, España Tevapharm A tiempo completo

Unlock a world of possibilities in pharmacovigilance with Teva Pharmaceuticals. As a physician, you will lead the safety profile of assigned products during clinical development, ensuring compliance with regulatory requirements and contributing to the submission of Common Technical Documents (CTD). Your expertise will be invaluable in leading cross-functional Product Safety Groups and representing PV on Product Label Working Groups. With strong knowledge of FDA and EMA regulations, you will excel in managing safety issues in pre-and post-marketing environments. Collaborate with international teams across multiple time-zones to drive global launch activities and due diligence on product safety profiles. In this role, you will have the opportunity to work with the world's leading manufacturer of generic medicines and contribute to the company's mission to make good health more affordable and accessible.

Company Overview

Teva Pharmaceuticals is a global leader in the pharmaceutical industry, committed to delivering innovative medicines that improve people's lives. Our company values diversity and inclusion, fostering a collaborative environment where employees from nearly 60 countries can thrive.

About the Role

This is an exciting opportunity for a seasoned physician to join our Medical Scientific Unit (MSU) as a Safety Physician, Director Pharmacovigilance. You will lead the safety profile of assigned products during clinical development, including Company Sponsored studies, Investigator Sponsored studies, Compassionate Use, and Disease Monitoring Programs. Your expertise will be essential in medical review of Individual Case Safety Reports (ICSRs), accountable for medical evaluation/interpretation of aggregate safety data, and leading risk management activities globally.

Responsibilities
  • Lead the safety profile of assigned products during clinical development, ensuring compliance with regulatory requirements
  • Contribute to the submission of Common Technical Documents (CTD)
  • Lead cross-functional Product Safety Groups and represent PV on Product Label Working Groups
  • Manage safety issues in pre-and post-marketing environments with strong knowledge of FDA and EMA regulations
  • Collaborate with international teams across multiple time-zones to drive global launch activities and due diligence on product safety profiles
Requirements

To succeed in this role, you will need:

  • MD or equivalent degree
  • Completion of an accredited Residency/Specialty program and Board Certification or Eligibility
  • 5 years of experience in pharmacovigilance and drug safety area as a safety physician
  • Strong knowledge of FDA and EMA regulations (GVP, GCP)
  • Experience with NDA/BLA submissions in the US and MAA in Europe
Benefits

We offer a competitive salary range of $150,000 - $200,000 per annum, commensurate with experience, plus benefits including health insurance, retirement plan, and paid time off. The estimated annual salary is $175,000.



  • Madrid, Madrid, España ASPHALION A tiempo completo

    Pharmacovigilance Expert WantedWe are seeking a highly skilled and experienced pharmacovigilance expert to join our team as a Lead Pharmacovigilance Project Manager. In this role, you will play a crucial part in ensuring the safety of patients by leading pharmacovigilance project management and inspiring a team dedicated to advancing patient safety.Key...


  • Madrid, Madrid, España ASPHALION A tiempo completo

    Job DescriptionAt Asphalion, we are committed to advancing patient safety through innovative pharmacovigilance solutions. As a Lead Pharmacovigilance Specialist, you will play a pivotal role in shaping our team's approach to vigilance project management.Main ResponsibilitiesElevate Patient Safety by orchestrating a symphony of vigilance, ensuring every note...


  • Madrid, Madrid, España Primevigilance A tiempo completo

    We are PrimeVigilance, a mid-size pharmacovigilance service provider established in 2008. Our global organic growth year after year has enabled us to expand our presence across Europe, North America, and Asia, covering services within Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.As a Global Pharmacovigilance Specialist,...


  • Madrid, Madrid, España Ergomed A tiempo completo

    About PrimeVigilancePrimeVigilance, a leading pharmacovigilance service provider, offers exciting opportunities for skilled professionals. We are part of Ergomed Group, a specialized mid-size company established in 2008.Job DescriptionWe are looking for a highly motivated Global Pharmacovigilance Specialist to join our team. As a PV Officer, you will work...

  • Pharmacovigilance Lead

    hace 3 días


    Madrid, Madrid, España Pivotal A tiempo completo

    About the RoleWe are looking for a seasoned Senior Safety Officer to join our team and provide expertise in pharmacovigilance and safety data management. The successful candidate will have a deep understanding of GCPs/ICH and international regulations, as well as experience in MedDRA coding and study coding reviews.Responsibilities will include preparing and...


  • Madrid, Madrid, España Empresa Reconocida A tiempo completo

    Job DescriptionWe are seeking a highly skilled Global Safety and Pharmacovigilance Delivery Director to join our team at Empresa Reconocida in Bangkok, Thailand.About the RoleThis is an exceptional opportunity for a seasoned professional to lead our safety and pharmacovigilance projects, working closely with clients and internal stakeholders to deliver...


  • Madrid, Madrid, España Prime Vigilance Ltd A tiempo completo

    Company OverviewPrimeVigilance Ltd is a renowned pharmacovigilance service provider established in 2008. The company has achieved remarkable global organic growth year after year, with staff based across Europe, North America, and Asia.The team at PrimeVigilance provides first-class support to pharmaceutical and biotechnology partners, maintaining...


  • Madrid, Madrid, España Prime Vigilance Ltd A tiempo completo

    Company Overview: PrimeVigilance Ltd is a leading provider of pharmacovigilance services, established in 2008. With a strong presence in Europe, North America, and Asia, we offer comprehensive support to pharmaceutical and biotechnology companies.About the Role: We are seeking a Senior Pharmacovigilance Associate to join our team. As a key member of our...


  • Madrid, Madrid, España Prime Vigilance A tiempo completo

    We are PrimeVigilance, a leading provider of pharmacovigilance services established in 2008. Our global presence, with staff based across Europe, North America, and Asia, enables us to deliver high-quality support to pharmaceutical and biotechnology partners worldwide.Our MissionWe aim to provide exceptional service by maintaining long-lasting relationships...


  • Madrid, Madrid, España ASPHALION A tiempo completo

    About the RoleAs a Medical Director of Pharmacovigilance and Patient Safety at ASPHALION, you will be responsible for leading our team in pharmacovigilance project management and ensuring patient safety.Main Responsibilities:Global Literature Review: Conduct weekly literature reviews globally and locally to stay ahead of safety insights.Case Management:...


  • Madrid, Madrid, España Prime Vigilance Ltd A tiempo completo

    OverviewPrimeVigilance Ltd is seeking a highly skilled PV Officer to join our team. As a key member of our case processing team, you will be responsible for managing Individual Case Safety Reports (ICSRs) from various sources, including post-marketing and clinical trials. Your primary goal will be to ensure compliance with applicable regulations,...


  • Madrid, Madrid, España Parexel A tiempo completo

    Company OverviewParexel is a leading biopharmaceutical services company dedicated to improving global health. We provide a comprehensive suite of services that enable our clients to transform scientific discoveries into new treatments. Our team is committed to upholding the highest standards of quality, respect, and accountability.About the RoleWe are...


  • Madrid, Madrid, España Ergomed A tiempo completo

    We are Ergomed, a specialist pharmacovigilance service provider, and we're seeking a skilled Pharmacovigilance Case Processing Specialist.About UsAs a leading player in the field, we've achieved global organic growth year after year. Our team members are based across Europe, North America, and Asia, providing exceptional support to our pharmaceutical and...


  • Madrid, Madrid, España Biomapas A tiempo completo

    About Pharmacovigilance at BiomapasWe are seeking a skilled Pharmacovigilance Expert to join our team in Spain. This role is focused on ensuring the safety of medications by monitoring, assessing, and communicating adverse events.Main Responsibilities:Local Safety Officer: Act as the primary contact for local pharmacovigilance activities, ensuring compliance...


  • Madrid, Madrid, España Primevigilance A tiempo completo

    **About Us**We are PrimeVigilance, a reputable pharmacovigilance service provider with a strong presence in the industry. Established in 2008, we have achieved consistent global growth and built a network of skilled professionals across Europe, North America, and Asia.Our team is dedicated to providing exceptional support to pharmaceutical and biotechnology...


  • Madrid, Madrid, España Prime Vigilance Ltd A tiempo completo

    PrimeVigilance is a specialist pharmacovigilance service provider that has achieved global organic growth year after year. We are proud to have staff based across Europe, North America, and Asia, covering services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. Our first-class support to pharmaceutical and biotechnology...


  • Madrid, Madrid, España Ergomed A tiempo completo

    **Job Overview**Ergomed, a leading pharmacovigilance service provider, seeks an experienced Regulatory Intelligence expert to join our team. As a key member of our regulatory affairs department, you will be responsible for providing high-quality intelligence and support to drive the development of our regulatory strategies.**Key Responsibilities**Provide...


  • Madrid, Madrid, España Healthcare Businesswomen'S Association A tiempo completo

    Job Description SummarySucceed as the scientific and operational safety leader of the Medical Safety Team, overseeing a portfolio to drive patient safety excellence. Contribute to Sandoz results through strategic medical/scientific safety leadership.About the Role:This position serves as the scientific safety leader for assigned high-profile programs, making...


  • Madrid, Madrid, España Prime Vigilance Ltd A tiempo completo

    About UsPrimeVigilance Ltd, a leading pharmacovigilance service provider, offers an exciting opportunity for a talented individual to join our team as a PV Officer. Our company, part of the Ergomed Group, has achieved global organic growth year after year, with staff based across Europe, North America, and Asia.We provide first-class support to our...


  • Madrid, Madrid, España Sobi Group A tiempo completo

    Company OverviewSobi Group is a leading biopharmaceutical company dedicated to developing and delivering innovative therapies for people living with rare diseases. Our team of passionate professionals shares a commitment to making a difference in the lives of patients worldwide.SalaryWe offer a highly competitive salary package, including an estimated annual...